FDA Approves First Photodynamic Therapy for Basal Cell Carcinoma

The U.S. Food and Drug Administration has approved aminolevulinic acid hydrochloride 10% topical gel (Ameluz), used together with red light photodynamic therapy (PDT), for the treatment of superficial basal cell carcinoma (BCC) in adults.

It’s a milestone with a “first”: this is the first and only photodynamic therapy the FDA has ever approved to treat a skin cancer — and the only topical PDT in the United States approved for both a precancerous condition, actinic keratosis, and a skin cancer.

What it means for patients. Superficial BCC is often found on the trunk, arms, and legs, and frequently appears as more than one lesion. Until now, treatment options that avoid surgery have been limited. This approval gives people with superficial BCC a nonsurgical, tissue-sparing option that can be done in a dermatologist’s office — which may matter especially for anyone with multiple spots, lesions in cosmetically sensitive locations, or reasons to avoid surgery.

The evidence behind it. The approval is based on a phase 3 clinical trial in 187 adults with superficial BCC. Patients who received the gel plus light therapy had a complete response of the main treated lesion 66% of the time, compared with 5% of those who received the light therapy with a placebo gel. Full clinical clearance of all treated lesions was seen in 83% of patients. The most common side effects were reactions at the application site, consistent with the treatment’s known safety profile.

“For many patients with superficial BCC — those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not be preferred — treatment options have been limited,” said M. Shane Chapman, MD, MBA, in Biofrontera’s September 14, 2026, news release. “This FDA approval gives us a rigorously studied, nonsurgical option that we can deliver in our office.”

The bottom line for you. This approval does not replace surgery, which remains the most common and effective treatment for BCC — it adds an option for one subtype, superficial BCC. If you notice a new, changing, or concerning spot on your skin, don’t wait: bring it to your healthcare provider’s attention. BCC is highly treatable when it’s found early.

Source: Biofrontera news release, September 14, 2026, as reported by The ASCO Post and Oncology/Cancer Network.